← Back to Search

Fluoride Dentifrice

Optimized Fluoride Toothpaste for Cavities

Phase 3
Waitlist Available
Led By Domenick Zero, DDS, MS
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be wearing a removable mandibular partial denture with sufficient room to accommodate two 4 mm round specimens in the buccal surface of two posterior denture teeth on the same side
Be between 18 and 85 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two weeks
Awards & highlights

Study Summary

This trial tested whether a special fluoride toothpaste can reduce tooth decay better than regular fluoride toothpaste.

Who is the study for?
This trial is for adults aged 18-85 with good medical and dental health, no active cavities or gum disease, and who wear a lower partial denture. Participants must not be pregnant, breastfeeding, planning to become pregnant during the study, or have conditions that could affect their safety. They should not have taken antibiotics or participated in another clinical study within the last 30 days.Check my eligibility
What is being tested?
The study aims to compare an optimized fluoride toothpaste (1100 ppm F as sodium fluoride Test Product) against a standard fluoride toothpaste (1100 ppm F as sodium fluoride) and a placebo without fluoride (0 ppm F). It will assess which better promotes remineralization of teeth using an in situ caries model.See study design
What are the potential side effects?
Since this trial involves commonly used dental products like toothpaste, side effects are expected to be minimal. However, there may be potential risks of hypersensitivity reactions if participants are allergic to any ingredients in the test products.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I wear a removable lower jaw denture that can fit two small samples on the inside of back teeth on one side.
Select...
I am between 18 and 85 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and two weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Surface Microhardness Recovery (%SMH Recovery)
Secondary outcome measures
Enamel Fluoride Uptake (µg F/cm2)
Integrated Mineral Loss (∆Z)
Lesion Depth (µm)
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Treatment Period 3Experimental Treatment3 Interventions
0 ppm F (placebo, negative control,1100 ppm F as sodium fluoride (positive control), 1100 ppm F as sodium fluoride Test Product
Group II: Treatment Period 2Experimental Treatment3 Interventions
0 ppm F (placebo, negative control,1100 ppm F as sodium fluoride (positive control), 1100 ppm F as sodium fluoride Test Product
Group III: Treatment Period 1Experimental Treatment3 Interventions
0 ppm F (placebo, negative control,1100 ppm F as sodium fluoride (positive control), 1100 ppm F as sodium fluoride Test Product
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
0 ppm F (placebo, negative control)
2023
Completed Phase 3
~80
1100 ppm F as sodium fluoride (positive control)
2023
Completed Phase 3
~60
1100 ppm F as sodium fluoride Test Product
2023
Completed Phase 3
~60

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
993 Previous Clinical Trials
1,095,237 Total Patients Enrolled
HALEONIndustry Sponsor
29 Previous Clinical Trials
4,120 Total Patients Enrolled
Domenick Zero, DDS, MSPrincipal InvestigatorIndiana University
1 Previous Clinical Trials
28 Total Patients Enrolled
~33 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top